1. IHE Clinical Laboratory Update
HIMSS 2006 – Interoperability Showcase
François Macary, AGFA HCES IHE Lab Committee co-chair

2. Agenda Lab domain: Scope and Work Reminder of Lab Scheduled Workflow
Lab Device Automation
Lab Information Reconciliation
Lab Point Of Care Testing
Lab Code Set Distribution

3. Laboratory Technical Framework
General scope:
Ordering, placing, scheduling and performing clinical laboratory tests within acute care settings.
Bound to in vitro testing
Microbiology included.
Pathology and blood banks excluded.
The first profile LSWF addresses acute care settings

4. The major problems to solve
Reduce over-ordering and over “blood-drawing”
By consolidating the lab results in a common repository shared by all wards in charge with the patient
By sharing the opened orders
Bring the accurate lab results to the clinician, in time for clinical decision
Without flooding the ward with paper reports
Without flooding the lab with phone calls

5. The IHE Laboratory Committee
Cochairs: Yoshimitsu Takagi - Hitachi
Francois Macary - Agfa Healthcare IT
Contributing countries
France
Japan
Germany
Italy
The Netherlands UK
US (1 from CLSI)
Development started in 2003
1st profile in November 2003
10 systems validated in 2004
12 systems validated in 2005
4 new profiles for connectathon 2006

6. Laboratory Scheduled WorkFlow
Three major use cases:
Externally placed order with identified specimens
Specimens identified on the container with a barcode label
Externally placed order with specimens unidentified or to be collected by the laboratory
The specimens unidentified in the message placing the order
Filler order with specimens identified by the laboratory
Order created in lab. Order number allocated afterwards
« Laboratory Scheduled Workflow » supports three kinds of organizations that can live together within the same healthcare enterprise:
In the first use case the care unit staff collects the specimens and its management system (actor « Order Placer ») gives a unique identifier to each one. The specimens are identified with barcode labels stuck on the containers. The message carrying the order from the care unit to the laboratory embeds all specimen information (ID, who collected it, when, how, …). The specimens may arrive at the laboratory before or after the electronic order. The laboratory staff checks up the specimens with the order. Should a specimen be damaged or lost, the laboratory application (actor « Order Filler ») sends back a message asking for a new one.
In the second use cases the specimens are always identified by the laboratory system, either because the laboratory staff (the phlebotomist) collects them, or because the ordering provider application is unable to identify them.
The third use case supports the situations in which the order is directly entered on the laboratory information system. This happens when the order has been received on a paper form from a third party or when the laboratory generates a new order to complete an existing one with deeper investigations. (e.g. adding antibiotic susceptibilities testing after a microorganism has been found).

7. IHE Laboratory: LSWF Patient Administration Ward or EHR Clinical
Rad-1, Rad-12
Rad1, Rad-12
Patient demographics & visit
ADT
Ward or EHR
Clinical
Laboratory
Lab-1: Placer order
Order Placer
Order Filler
Lab-2: Filler order
Lab-4: Work order
Lab-5: Results
Order Result Tracker
Lab-3: Results
Automation Manager

8. Laboratory Device Automation (LDA)
Demographics
Demographics
ADT
Placer order
Order Placer
Order Filler
Filler order
Work order
Results
Results
Order Result Tracker
Automation Manager
LDA
Work Order Steps
Analyzer
Pre/post processor
LSWF

9. Scope of LDA
Workflow between an Automation Manager and its set of automated devices.
Each Work Order is split into a sequence of steps, each of which uses a specimen on a device.
Scope limited to devices operated by the lab staff.

10. No candidate for year 2006? LIS vendors
Small companies with specialized software
…Sometimes bought by devices manufacturers
No standard available
Automation
Manager
One standard available: ASTM E1394
+ one future ISO standard
IHE proposed one common standard: HL7 2.5 – chap 13
Pre/post analytic devices
Analyzers
Manufacturers

11. Laboratory Information Reconciliation (LIR)
Reconcile clinical lab observations produced on specimens collected from misidentified or unidentified patient. (Same thing as PIR in Radio land)
Reconcile clinical lab observations produced on specimens before the orders are created: Results for unknown orders. (Different from PIR)
LIR profile depends upon LSWF and LDA profiles
No added transactions

12. LIR: one example of process flow

13. Laboratory Point Of Care Testing
Scope:
In vitro tests performed on point of care or patient bedside
specimen collected, tested at once and eliminated
No pre or post-processing
Results used immediately by the care provider
Supervision by a clinical laboratory of the hospital
Training provided to the ward staff
Provision of reagent
Supervision of quality control
Clinical validation a posteriori

14. Benefits of LPOCT
Results obtained at once  increases the efficiency of clinical decisions
Minimizes the blood quantity drawn from the patient, because of the immediate use of the specimen. E.g. Two drops are enough to test blood gas, electrolyte and hematocrit of a new-born baby.
Preserving a high level of quality of the POCT process through its supervision by a clinical laboratory.

15. Examples of LPOCT
Portable blood gaz and chemistry analyzer used by the nurse in a neonatology ward
Blood gas analyzer permanently installed in the surgery theater
Glucometer used by the patient in home care
Workstation on which the nurse manually enters the results of pregnancy stick tests.

16. The Actors of LPOCT
Point Of Care Result Generator (POCRG)
Produces the results from a specimen by testing on a specimen, or calculation or manual entry
Point Of Care Data Manager (POCDM)
Administers a set of POCRG, controls their process. Collects the patient and QC results. Forwards the patient results to the Order Filler
Order Filler
Recipient of POCT results. Stores the results within orders. Performs a posteriori clinical validation
Point of care results
Point of care patient results

17. LPOCT: Actors and Transactions
Ward
Clinical
laboratory
Lab-30:
Initiate testing on a specimen
Point Of Care Result Generator
Point Of Care Data Manager
Lab-31:
Performed observation set
(patient or QC results)
Lab-32:
Accepted observation set
(patient results)
Order Filler
POCDM and Order Filler are assumed to be provided with up-to-date patient demographic data
(for instance by PAM or PDQ)

18. Five major use cases
Observations to match with an existing order, real-time patient identity checking
Unordered observations, real-time patient identity checking
Unordered observations on a POCRG with an intermittent link (no patient identity check)
Manual entry of unordered observations
QC results

19. Based on HL7 early v3 in XML
Selected standard
POCT 1-A, published by CLSI (ex NCCLS)
Based on HL7 early v3 in XML
HL7 v2.5
POCRG
POCDM
Order Filler

20. Laboratory Code Set Distribution
The goal of this profile is to simplify the configuration of the systems involved in the Laboratory Scheduled Workflow.
The Laboratory Code Set Distribution Profile offers the means to share the same set of test/observation codes between different actors.
Other information can be also exchanged like presentation of results, laboratory codes (in which lab a test is performed), units …

21. LAB-51: Laboratory Code Set Management (REP)
LCSD: Use Case 1
Laboratory Code Set Master
Laboratory Code Set Consumer
Creates observation, test, battery codes
LAB-51: Laboratory Code Set Management (REP)
Replaces Observation/Test/Battery Code Sets
All Observation, Test and Battery code sets of the Consumer are replaced by the code sets sent by the Master. This Use Case is used both for initialization as well as periodic (weekly, monthly) update.

22. LCSD - Standard used HL7 V2.5: Master Files
Messages rich enough to transport other information than just observation/test/battery codes :
presentation of the results
Units of measure
Laboratories fulfilling this test

23. Next Steps for IHE Lab in 2006 CDA rel 2 Lab Report
Beyond need to request/receive results, also need to share/distribute complete validated lab reports with structured tests results as one object.
Laboratory results communicated via messaging are point-to-point (request/result) and not human readable
Laboratory results can only be shared when “approved” for release by an authorized source: a document oriented laboratory report is needed.
Human readable and structured coded lab reports are necessary in a wide variety of Patient Care Coordination use cases

24. How can I participate? As a Provider or Vendor Contributor
Offer Clinical Use Case Input to Drive IHE Profile Development
Become a member of relevant domain’s Planning or Technical Committees
Become a member of relevant Regional/National Committees
Help to shape IHE’s future direction
As a Vendor Participant
Respond to Public Comments of Domain Supplements
Attend the June Educational Workshop
Participate in Connect-a-thons and Demonstrations
As a Provider/Consultant Participant
Attend Demonstrations and include IHE Integration Profiles in your RFPs and Integration Projects.

26. IHE Web site: www.IHE .net
Frequently Asked Questions
Integration Profiles in Technical Frameworks: See Volume 1 of each TF for Use cases
Cardiology
IT Infrastructure
Laboratory
Patient Care Coordination
Radiology
Connectathon Result:
Vendor Products Integration Statements
Participation in Committees & Connectathons